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Arm 1, Single Dose: Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 or Day 1 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Arm 2, Two Doses: Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 or Day 1 + Day 4 of Cycle 2. Participants randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2); or Group 2 (No Fosaprepitant Cycle 1 and Fosaprepitant Cycle 2). Dexamethasone intravenously (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.

Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)

5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy

5HT3 receptor antagonist

Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.

Ifosfamide-based chemotherapy (AI)

25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.

Prior to ifosfamide (Day 1) - 500 mg/m\^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m\^2. The mesna infusion complete 24 hours after last dose of ifosfamide.

2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).

2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied.

Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Study Groups:

If you are found to be eligible to take part in this study, you will receive fosaprepitant during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to 1 of 2 study groups, each with 2 divisions:

* If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.
* If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.
* If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.
* If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.

You and the study staff will know to which group and division you are assigned. Each time you receive the drug, you will receive it by vein over about 20-30 minutes.

You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam, diphenhydramine, and promethazine). You will sign a separate consent form that will describe these treatments in detail, along with their risks.

You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent nausea and vomiting.

Before each chemotherapy cycle, you will be given a study diary. Each day, you will record any side effects you may . You should bring your study diary to every study visit so the study staff can review it.

Study Visits:

Before each cycle that you receive fosaprepitant, the following tests and procedures will be performed:

* You will have a physical exam.
* Your vital signs, weight, and performance status will be recorded.
* You will fill out the same questionnaire you did at screening.
* You will be asked about any other drugs you may be taking. Be sure to tell the study doctor about all drugs (including vitamins, herbal products, and nutritional supplements), because some drugs/substances will cause side effects when taken at the same time as fosaprepitant.
* Blood (about 5 teaspoons) will be drawn for routine tests.

Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for routine tests.

Pharmacokinetic Testing:

On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures the amount of study drug in the body at different time points. The blood will be drawn before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours after the infusion.

Length of Study:

You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You will no longer be able to take the study drug if the disease gets worse or if intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam.
* Your vital signs, weight, and performance status will be recorded.
* You will fill out the same questionnaire you did at screening.
* You will be asked about any other drugs you may be taking.
* Blood (about 5 teaspoons) will be drawn for routine tests.

This is an investigational study. Fosaprepitant is FDA approved and commercially available in combination with other drugs for the prevention of nausea and vomiting that may be caused by chemotherapy. It is investigational to study how fosaprepitant may affect the drug levels of ifosfamide in the blood and how many doses should be given.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen

Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

Number of participants for different study groups are: 22 single dose, Arm A (11 from group 1, cycle 1 \& 11 from group 2, cycle 2); 17 two doses, Arm B (9 from group 1, cycle 1 \& 8 from group 2, cycle 2); 37 control cycle \[Arm A: 21(12 from group 1, cycle 2 \& 11 from group 2,cycle 1); Arm B: 16(8 from group 1, cycle 2 \& 8 from group 2,cycle 1)\].

Control Cycle (Arm A/Arm B)

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).

Arm A: Single Dose, Day 1

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).

Arm B: Two Doses, Day 1 + Day 4

Total

Between 19 and 65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology

Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.

Complete Response

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm A: Single Dose, Group 1

Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm A: Single Dose, Group 2

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm B: Two Doses, Group 1

Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m\^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m\^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day for a total of 6 gm/m\^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m\^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m\^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Arm B: Two Doses, Group 2

Cycle 1

Cycle 2

Dermatologic Agents

Ondansetron

Palonosetron

Serotonin 5-HT3 Receptor Antagonists

Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

aprepitant

palonosetron hydrochloride

ondansetron

dexamethasone

Rachel Layman

Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens

PRIMARY OBJECTIVES:

I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.

ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.

After completion of study treatment, patients are followed up for 7 days.

Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).

We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.

The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.

The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Patients were given a diary on the day of treatment to record symptoms experienced on days 1 through 6. Although symptoms were documented on days 1 through 6, they were only evaluated based upon days 1 through 5. The additional day of recording was instituted to ensure the investigators captured the entire day 1 through time period.

Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4

Arm A

Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4

Arm B

Age, Categorical

Rachel Layman, MD

Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.

Arm A (Palonosetron 0.25 mg IV on Day 1)

Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.

Arm B (Ondansetron 24 mg Oral on Day 1)

Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication

Acute CR (Complete Response)

Delayed CR (Complete Response)

Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours

Visual Analog Scale (VAS) Scores

Use of Rescue Medication for Each Treatment Arm

Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours

Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4

Overall Study

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Gabapentin

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.

Aprepitant vs. Gabapentin

Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.

Stanley Cheshire

1. To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.
2. To evaluate and compare the safety profile associated with each anti-emetic regimen.
3. To assess subject satisfaction with anti-emetic therapy.

The purpose of study is to compare the effectiveness of aprepitant and gabapentin in treating "delayed" (days later) nausea and/or vomiting for patients receiving chemotherapy treatment for cancer. Patients on the study will receive aprepitant or gabapentin in addition to the standard medications used to prevent nausea and vomiting. Aprepitant is approved by the FDA for nausea and vomiting. Gabapentin is approved by the FDA for the treatment of seizures but it may be effective in controlling nausea and vomiting due to chemotherapy. Subjects receiving aprepitant will be receiving a proven treatment for delayed nausea and vomiting, while subjects receiving gabapentin will be receiving a drug that has only shown limited effectiveness.

Patients are eligible for participation in this study because they are going to receive chemotherapy that may cause nausea or vomiting. If patients have delayed nausea or vomiting after the first cycle of treatment, they will be offered a chance to receive additional treatments with their second cycle of chemotherapy. The University of New Mexico Health Sciences Center is sponsoring the study.

The first 40 patients enrolled in the study will participate in the pilot phase of the study. A pilot study is a smaller version of a full study to determine how effective the treatments are. All 40 patients in the pilot phase of the study will come from UNM. If the pilot phase is found to be successful, then the study will continue and approximately 200 patients will eventually be enrolled. The full study will be conducted at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC), the New Mexico VA Healthcare System, and at members of the New Mexico Cancer Care Alliance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen	NCT01490060	Sarcoma Chemotherapy-in... Effects of Chem... Adverse Effects...	Fosaprepitant Dexamethasone 5HT3 receptor a... Ifosfamide-base... Doxorubicin Mesna Ifosfamide Vincristine	18 Years - 65 Years	M.D. Anderson Cancer Center
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)	NCT01640340	Malignant Neopl...	aprepitant palonosetron hy... ondansetron dexamethasone	18 Years - 88 Years	Ohio State University Comprehensive Cancer Center
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)	NCT01640340	Malignant Neopl...	aprepitant palonosetron hy... ondansetron dexamethasone	18 Years - 88 Years	Ohio State University Comprehensive Cancer Center
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)	NCT01640340	Malignant Neopl...	aprepitant palonosetron hy... ondansetron dexamethasone	18 Years - 88 Years	Ohio State University Comprehensive Cancer Center
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance
Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting	NCT00250744	Cancer	Aprepitant vs. ... Aprepitant vs. ...	18 Years -	New Mexico Cancer Care Alliance

Spots Global Cancer Trial Database for emetogenic chemotherapy